# K212850: ComfortPro Blue Nitrile Examination Gloves Powder Free

- Pathway: 510(k) (Abbreviated)
- Applicant: Thai Rubber Industry Company Limited
- Decided: Dec 10, 2021 after 94 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K022548 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202384: Palm Care Blue Nitrile Examination Gloves Powder Free, Hi-Care Thai Gloves Co., Ltd. (2020) Summary page 4.

## Indications for use
ComfortPro Blue Nitrile Examination Gloves Powder free is disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K212850
Methodology: https://510kreport.com/methodology